ICN Biomedicals

Former California Governor Edmund Brown, Jr. and Roger Guillemin, MD/PhD, to the board of the Costa Mesa, Calif. firm. A winner of the Nobel Prize in Medicine, Guillemin is affiliated with the Salk Institute in La Jolla and the University of California at San Diego medical school.

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

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Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

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EU’s Critical Medicines Act: A Major Milestone Or Too Weak?

 

Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such a requirement for EU countries to prioritize the security of supply over price when procuring drugs.

EU Pharma Reform: Negotiations Could See Patient Voice ‘Discarded,’ Warn Patient Groups

 

An enhanced role for patients in the European Medicines Agency was a key proposal within the EU pharmaceutical legislation overhaul – but patient groups warn this provision could be scrapped or weakened due to ongoing negotiations.

User Fee Deadline Concerns Emerge As US FDA Buyout Offer Sweetened With Paid Leave

 

The buyout excludes reviewers, but not project managers. Experts said product reviews likely would be harmed if review team-specific project managers could take the buyout.